Senior Director Manufacturing Technical Operations

Found in: beBee S IE - 4 weeks ago

Ireland RPMGlobal Full time

Senior Director Manufacturing Technical Operations Location Ireland Requisition ID 2228 # of openings 1

Senior Director Manufacturing Technical Operations

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

· The Senior Director of Manufacturing Technical Operations will lead the manufacturing technical team in support of the oversight and management of Amicus external manufacturing network. This role requires a strategic leader with a strong background in biopharma/pharma manufacturing, regulatory compliance, and quality focus.

Roles and Responsibilities:

· Lead and manage the manufacturing technical operations team supporting commercial manufacturing activities and late-stage development activities.

· Develop and implement a comprehensive strategy for the manufacturing technical operations unit, aligning with the company's overall vision and goals

· Responsible for the manufacturing process lifecycle and continuous process verification program for small and large molecules.

· Responsible for timely execution of technology transfer projects and process improvement projects

· Responsible for supporting projects through the preparation and/or review of documents such as protocols, reports, master batch records, investigation reports, etc.

· Lead teams on troubleshooting and data analysis to solve technical problems in manufacturing to ensure manufacturing output and product quality are maintained.

· Support and lead risk assessments and manufacturing deviation investigations

· Work closely with other departments, including CMC, quality assurance and Global Regulatory Affairs, to ensure cohesive and integrated operational strategies.

· Collaborate with the CMO senior leadership teams to ensure any areas of conflict get resolved in a timely manner and escalate to senior management as appropriate if required Identify and mitigate risks associated with manufacturing operations, proactively implementing strategies to prevent deviations and ensure continuous improvement.

· Drive initiatives for process optimization, technology implementation and best practices to improve manufacturing operations.

· Foster strong relationships with internal and external stakeholders, ensuring alignment of manufacturing technical operation strategies with CMO and organizational goals.

Requirements

Educational Requirements

· Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related field.

Professional Work Experience Requirements

· 15+ years experience in pharmaceutical and/or biopharmaceutical manufacturing of drug substance, with a strong understanding of GMP and regulatory compliance.

· Excellent communication, negotiation, and CMO management abilities.

· Strong problem-solving skills and a proactive approach to driving continuous improvement in manufacturing processes.

Experience and Skills

· Project Management skills and coordination of CMO activities.

· Navigating change control review and approval process.

· CAPA implementation and CAPA effectiveness review.

· Experience with continuous manufacturing; upstream and downstream.

· Knowledge of batch record development and management for drug substance manufacturing.

· Problem-solving and troubleshooting skills.

· Ability to work independently or as part of a team.

· Strong verbal, written communication skills and strong interpersonal skills.

· Knowledge of lean manufacturing principles.

· Experience working in collaboration with CMO’s

· Hands on cell culture experience with cGMP commercial manufacturing

· Familiarity with perfusion bioreactor systems coupled with ATF and other harvesting technologies, Unicorn chromatography control system and Delta V.

· Knowledge of cGMP manufacturing of recombinant enzymes.

Other skills/Attributes

· Demonstrated alignment with Amicus Mission Focus Behaviors.

· Passion for rare disease and patient focused.

Location

· Ireland or UK.

Travel

· Travel to CMO’s may be required to meet business needs. Approx. 10% travel.

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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